CUFFALERT— 510(k) K081805

Substantially Equivalent

Sunmed

FDA 510(k) clearance K081805 for CUFFALERT, Substantially Equivalent on 2008-11-14. Applicant: Sunmed. Device class: 2.

Clearance details

Applicant: Sunmed
Product code: Code BSK
Device class: Class 2
Regulation: 21 CFR 868.5750
Advisory panel: Anesthesiology
Date received: 2008-06-26
Decision date: 2008-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.